ACUROX(R) and EMBEDA (TM) Data Highlighted at the College on Problems of Drug Dependence Annual Meeting
RENO, Nev., June 25 /PRNewswire/ -- King Pharmaceuticals, Inc. (NYSE: KG) today announced that the Company is presenting safety and efficacy data for ACUROX(R) and EMBEDA(TM) (ALO-01), two novel opioid analgesic formulations that are in development, at the 71st Annual Meeting of the College on Problems of Drug Dependence. King is also developing other pain medicines employing unique technology platforms designed to address risks associated with currently marketed opioids.
'We anticipate that ACUROX(R) and EMBEDA(TM), upon approval, will offer new therapeutic tools for physicians treating people living with pain,' said Eric Carter, Chief Science Officer of King Pharmaceuticals. 'Our expectation is that these novel technologies could become instrumental in a physician's arsenal of safe and effective pain medicines that can help with an overall risk management plan.'
Highlights of King's presentations and King supported presentations are as follows:
ACUROX(R) (oxycodone HCl/niacin) Tablets for the Treatment of Acute, Moderate to Severe Pain Following Bunionectomy Surgery in Adult Patients
ACUROX(R) Tablets are a unique composition of short-acting oxycodone HCl, niacin and functional inactive ingredients intended to relieve moderate to severe pain. A Phase III study evaluated the analgesic efficacy and safety of ACUROX(R) in adults with moderate to severe pain following bunionectomy surgery. The 405 participants received either two ACUROX(R) Tablets 7.5/30 mg, two ACUROX(R) Tablets 5/30 mg or two placebo tablets every six hours for 48 hours after surgery. Both doses of ACUROX(R) Tablets demonstrated significant reduction in pain compared to placebo. The adverse event profile was similar to that seen with short-acting oxycodone, and ACUROX(R) was generally well tolerated.
Evaluation of Plasma Naltrexone Concentrations Resulting From Use of ALO-01 (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules for Chronic Pain
EMBEDA(TM) Capsules (ALO-01), a novel opioid formulation, contain pellets of an extended-release formulation of morphine sulfate surrounding an inner core of naltrexone hydrochloride. EMBEDA(TM) is intended to treat moderate to severe chronic pain. This 12 month open-label safety study evaluated the plasma concentrations of naltrexone following use of ALO-01 (morphine sulfate and naltrexone hydrochloride). Samples were drawn to measure plasma concentrations (concs) of morphine (M) naltrexone (N) and its metabolite, 6-beta-naltrexol (6-beta-N) when taken as directed. Results showed that, when ALO-01 was taken as directed, steady state plasma morphine levels remain stable. Naltrexone and 6-beta-N do not accumulate; small amounts, when detected, were not dose related and not associated with clinically observable effects of opioid withdrawal or reduction of pain relief.
Phase II Study to Evaluate the Dose Response for Flushing, Safety and Tolerability of Escalating Doses of Niacin in Fasted and Fed Healthy Adult Volunteers
ACUROX(R) Tablets, with Aversion(R) Technology, are a composition of oxycodone HCl, niacin, and other inactive ingredients. The niacin ingredient can generate a temporary, but increasingly unpleasant effect, including flushing. A Phase II study was conducted to evaluate the dose response for niacin-induced flushing, the effect of food on niacin-induced flushing, and the safety and tolerability of varying doses of niacin.
